Comparing Warm Versus Cool Temperature Water During Colonoscopy

May 24, 2012 updated by: OHSU Knight Cancer Institute
The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. The hypothesis of this study is patients receiving screening colonoscopy utilizing the water insertion method with room temperature (cool) water will have similar pain scores and medication requirements compared to water insertion method using body temperature (warm) water.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening

Exclusion Criteria:

  • Patients undergoing colonoscopy for any other indication besides colon cancer screening
  • Patients with prior colonic resections
  • Patients with chronic narcotic or benzodiazepine use
  • Poor bowel preparation (i.e. Boston bowel preparation score < 8)
  • Patients with obstructing colonic lesions detected on colonoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Warm water
Body temperature (95-100 degrees F) water
Procedure: Warm vs Cool water
Body vs Room temperature water used during insertion of colonoscopy
EXPERIMENTAL: Cool water
Room temperature (68-73 degrees F) water
Procedure: Warm vs Cool water
Body vs Room temperature water used during insertion of colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose of sedation medication used (fentanyl and midazolam)
Time Frame: Duration of the colonoscopy; Up to 3 hours
Duration of the colonoscopy; Up to 3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient pain/discomfort score
Time Frame: During the day of the procedure; Up to 1 day
During the day of the procedure; Up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Investigators

  • Principal Investigator: M. Brian Fennerty, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (ESTIMATE)

March 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 25, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00007299

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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